A number of operating room table accessory devices have been developed in an attempt to safely restrain patients from moving on the surgical table while laying in the supine position. The supine position may be maintained when the table is horizontal, tipped laterally or tipped into a head up angulation or into a down angulation a position known in the industry as the Trendelenburg position where the angle of head down tilt typically ranges from 20° to 50° with respect to a ground surface.
It is well-known in the medical industry that, for performing modern surgical procedures requiring supine the upper extremities are to be restrained at the side of the patient. Traditional wisdom has dictated that the arms be restrained by wrapping a linen or a disposable draw sheet around the arm which is then tucked beneath the patient or the mattress. Historically, when positioning patients for surgical procedures requiring that the patient's arms are held against the patient's body, the surgical team has used woven or non-woven sheets to bundle the arm against the side of the body. One risk of operating room acquired patient nerve injury occurs when the arm is bundled and held against the body with excessive compression. Another known risk factor is that surgeon(s) or assistant(s) often inadvertently lean against the patient's arm when attempting to remain within an ergonomic arms-length of the operative site or while attempting to stabilize their posture if they become fatigued. Other, more serious, patient risks include instances when the patient monitoring lines may become disengaged or an intravenous line may become dislodged, kinked or occluded leading to a disruption in the flow of IV fluids. The resultant emergent situation requires that the anesthesia caregiver gain immediate access to the affected site. This normally requires time consuming “un-bundling” of the arm. After the refastening or repositioning or clearing the occlusion of the lines an even more difficult and time consuming re-bundling, of the arm is necessary.
Gaining rapid access to the upper extremity is important when the patient monitoring lines may become disengaged or an intravenous line may become dislodged, kinked or occluded leading to a disruption in the flow of IV fluids. Dealing with those issues often occurs when the patient is in the extreme head down tilted posture (Trendelenburg position). The risks of neuropathy increase when, after the emergency has been dealt with, the arm is not re-tucked properly. Problems with re-tucking occurs often when the team has reduced access to the draw sheet when the patient is covered with a surgical drape, in a darkened room and postured in 30° to 40° of Trendelenburg (head down tilt). The combination of the tilt of the table, gravity and weight of the appendage against a loosened restraint is known to be responsible for arms slipping out of the tucking restraint, and falling freely to the side which is known to create very serious injuries. This reportable event is considered to be extremely serious and places the patient at risk for painful and debilitating nerve and muscle injury.
Moreover, it is not uncommon in the performance of Minimally Invasive Surgery of organs of the pelvis as well for Robotic assisted surgery of organs of the pelvis that the patient's arms are restrained against the patient's body when the operating room table is tilted so that the patient is in an extreme head down tilted position (The Trendelenburg Position). Added to the normal degree of difficulty in “re-bundling” the patient arm is the fact that during the surgical procedure the patient is hidden under a sterile protective drape, in a darkened room, postured in an extreme head down position. While the “un-bundling” allows for repair or repositioning of the lines the “re-bundling” is difficult to properly accomplish. This is especially apparent when it must be done in a dark environment with the patient in an extreme head down posture while under the sterile protective drape. The “re-bundling” is often done so quickly and inadequately that it is commonly known that it is not an uncommon event that the weight of the arm combined with the effect of gravity will pull the arm free from the improperly “re-bundled” sheet.
It has been reported in the medical literature that compression related to tucking arms can be causal to neuropathy (nerve injuries). The Association of Operating Room Nurses (AORN) is the recognized governing body for developing the guidelines used by operating room nurses to position patients. In 2010, AORN issued specific guidelines on patient positioning recommending against the tucking of arms. Patient risks associated with tucking include: wrinkles in the draw sheet, arms sagging below the top level of the mattress, interference with physiologic monitoring and the inability to resuscitate during an emergency due to unrecognized IV infiltration in the tucked arm. There is also an increased risk for the patient to develop compartment syndrome in the upper extremity. Other risk factors for injury include surgeon(s) or assistant(s) inadvertently leaning directly against the patient's arm when attempting to remain within an ergonomic arms-length of the operative site or while attempting to stabilize their posture if they become fatigued.
A number of operating room table accessory devices have been developed in an attempt to restrain patient's arms at their sides during certain surgical interventions. One common concept includes the utilization of what is known in the industry as a toboggan restraint, which is a protective plastic containment shell fabricated with an integral horizontal component that slides under the surface of the operating room pad and is commonly kept in position by gravity and the patient's body weight bearing down on the device. The containment shell is lateral to the patient's arm which is often wrapped in a protective material such as egg crate foam or a gel material. The toboggan is then used to push the arm against the body using un-measurable compressive forces that are known in the medical literature to have caused nerve injury by placing strain on joints, nerves and vessels of the upper extremity involved. This is particularly critical if a patient has limited mobility or if the joints are affected by degenerative disease or damaged from injuries. The issue of “tucking and re-tucking” the arm after an emergent circumstance is only slightly less complicated than when tucking the arms with woven or non-woven materials such as linen.
Contemporary ergonomic issues include the common complaint of surgeons and surgical assistants that leaning against the “toboggan” arm restraint, in an attempt to remain within an ergonomic arms-length of the operative site or while attempting to stabilize their posture, is very uncomfortable. Most recently it has been discovered that when attempting to use the toboggan during robotic assisted laparoscopic procedures, the physical height of the toboggan is known to cause physical interference (often referred to as clashing) with the robotic arm which is often in close proximity to the side of the patient's body. This interference is known to restrict the range of motion required by the robotic arm and keeps it from performing optimally.
Another conventional device that emulates the setup and utility of woven or nonwoven sheets that are used for tucking arms utilizes foam sheets with self-adhering hook and loop fasteners that allow the foam fabric to wrap around the arm to hold it in place (one example shown in the photographs labelled as “prior art”). The device functions in much the same manner as tucking arms and offers little lateral support or protection for the arm. The absence of lateral support also increases the inherent risks that occur when the surgeon(s) or assistant(s) lean directly against the extremity. The device does not provide horizontal support for arms of large patients that extend beyond the outer edge of the operating room table mattress. This results in the arm sagging and exacerbates the risk of the arm coming into contact with the hard edged surface of the accessory rail of the table. This is known to cause irreparable nerve injury.
This instant invention results from an attempt to provide an innovative device that eliminates or minimizes intraprocedural patient injury, meets or exceeds the clinical guidelines in the medical literature described herein regarding needs for safety, and provides fast and easy anesthesia access and exposure to lines, IV's and ports.
It is to be understood that both the foregoing general description and the following detailed description present example and explanatory embodiments of the invention, and are intended to provide an overview or framework for understanding the nature and character of the invention as it is claimed. The accompanying drawings are included to provide a further understanding of the invention and are incorporated into and constitute a part of this specification. The drawings, photographs, and attachments illustrate various example embodiments of the invention, and together with the description, serve to explain the principles and operations of the invention.